Chiesi Group said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that the EMA approve its extra-fine triple combination inhaler for the treatment of chronic obstructive pulmonary disease. The Trimbow device combines an inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist. The healthcare group said it is […]
Wall Street Beat
QT Vascular shops coronary assets
QT Vascular said today that it’s in discussions to sell its coronary assets, apart from the Chocolate PTA device it’s already looking to deal to Medtronic (NYSE:MDT). Earlier this month, QT Vascular said Medtronic agreed to pay $28 million for an option on the Chocolate PTA non-drug-coated balloon for treating peripheral vascular disease, after inking a 5-year […]
EuroPCR Roundup: Bioresorbable stents show promise, but metallic drug-eluting stents remain standard
Abbott’s (NYSE:ABT) bioresorbable scaffold has been plagued with a myriad of troubling data, including a study that showed that the device is associated with an increase in thrombosis and target lesion failure. In April, Abbott pulled the stent from European markets. In response to widespread criticism of the technology, the EuroPCR team released a statement this […]
ViaCyte looks to cell replacement therapy to cure Type I diabetes
ViaCyte said today that it will begin clinical trials of its novel islet cell replacement therapy in development as a potential cure for Type I diabetes, after landing regulatory wins from the FDA and Health Canada. The company’s PEC-Direct candidate delivers stem cell-derived pancreatic progenitor cells in a device that is designed to enable direct […]
Alere ticks up on delayed Q4, 2016 prelims
Share prices ticked up today for Alere (NYSE:ALR) after the diagnostics company released long-delayed preliminary financial results for the 4th quarter and full year 2016. Waltham, Mass.-based Alere said in March that it would miss the deadline for releasing last year’s results due to an investigation of inappropriate conduct at its South Korean Standard Diagnostics subsidiary. It […]
Quvium’s cough monitor boosts compliance by involving caregivers
When Steven Schmidt worked at Vertex Pharmaceuticals (NSDQ:VRTX), Eric Olson – the man who led the development of the 1st drug to treat the underlying causes of cystic fibrosis – asked Schmidt to look into ways that families could become more engaged with managing a patient’s condition. Olson pointed towards a publication that showed that […]
BTG touts Ekos data from pulmonary embolism trial
BTG (LON:BTG) touted data today from the Optalyse PE trial showing that pulmonary embolism can be treated effectively with Ekos over a shorter period and with smaller doses of thrombolytic drugs compared to the current standard. The 101-patient trial randomized participants to receive therapeutic anticoagulation and Ekos acoustic pulse thrombolysis therapy at different doses for different lengths […]
Sanofi’s insulin biosimilar wins EMA committee recommendation
Sanofi (NYSE:SNY) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended its insulin lispro biosimilar for approval. Insulin lispro Sanofi is a biosimilar of insulin lispro, a fast-acting insulin analog made using recombinant DNA technology. Sanofi’s biosimilar has the exact same amino acid sequence as its reference product. The positive opinion […]
Teva to cut 500 jobs after closing Hungary facility
Teva Pharmaceutical (NYSE:TEVA) is reportedly closing its sterile injectables plant in Godollo, Hungray and 500 workers could lose their jobs. The generics-maker is slated to close or sell the facility by the end of 2018. The plant stopped production last year after the FDA found an array of sterility issues that the agency said put […]
The key components of a well-designed wearable: Sense, analyze, act
One of the earliest uses of a wearable technology was recorded during Emperor Nero’s rule over the Roman Empire from 54 to 68 AD. A brutal leader, the emperor enjoyed watching his gladiators fight in crowded stadiums. As Nero watched his fighters battle, he was confronted with a problem – the glaring sun made it difficult […]
New FDA commish extends time for comments on off-label communication rules
Under the agency’s new commissioner, Dr. Scott Gottlieb, the FDA has reportedly extended the time for comments in its review of off-label communication rules. In the past, Gottlieb has advocated for off-label uses of medical products, arguing that doctors are adequately trained to make decisions in the best interest of their patients. The FDA maintains […]